2-[[4-[(2-cyanoethyl)ethylamino]phenyl]azo]-5-nitrobenzonitrile

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Disperse Red 073

IUPAC Name:

Disperse Red 073

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Housing: all animals were housed in single cages.
- Diet: a standard laboratory diet was provided ad libitum. The batch of the diet used for the study was analysed for chemical and microbiological contaminants.
- Water: ad libitum.
- Acclimation period: all animals were acclimatized to the environment for a period of five days prior to the start of the study.
- Health check: prior to the test, the eyes of each rabbit were examined for pre~existing casual injury.

ENVIRONMENTAL CONDITIONS
- Temperature: the room temperature was maintained within a median of 23 ± 2°C recorded by a maximum-minimum thermometer.
- Humidity: 50 ± 10 % was measured by a hygrometer.
- Air changes: the rate of air exchange was maintained at approximately 15 changes/hour.
- Photoperiod: the light/dark cycle was 12 hours.

Test system

Type of coverage:

occlusive

Preparation of test site:

other: clipped and abraded skin

Vehicle:

other: dimethylsulphoxide

Controls:

yes, concurrent no treatment

Amount / concentration applied:

- Amout: 1.0 ml
- Vehicle: test item was diluted in DMSO to a 50 % suspension.

Duration of treatment / exposure:

24 hours

Observation period:

72 hours

Number of animals:

Three males and three females

Details on study design:

TEST SITE
- Area of exposure: 24 hours prior to the test, the skin on the back of the animals was clipped by means of an electric clipper and the skin was investigated for pre-existing injuries. Test item was introduced under a square patch of surgical gauze measuring 6.5 cm2.
- Type of wrap if used: the animals were immobilized with patches secured in place by a plastic patch and the entire trunk was wrapped with a plasic sIeeve for the 24 hour exposure.

SCORING SYSTEM:
The irritation was measured by patch test technique on the intact and abraded skin.
After 24 hours, the patches were removed and the resulting reactions were evaluated on the basis of the code of Federal Regulations, Title 16, Section 1500.41.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: 6/6

Time point:

24/48/72 h

Score:

0

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

edema score

Basis:

animal: 6/6

Time point:

24/48/72 h

Score:

0

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

The irritation score was 0.0
The substance can be considered as non irritating, according to the ETAD-Subcommittee for Toxicology.

Applicant's summary and conclusion

Interpretation of results:

other: not classified, according to the CLP Regulation (EC) No 1272/2008

Conclusions:

Non irritating

Executive summary:

Six rabbits (three males and three females) were used to test the skin irritation potential of the substance. The abraded and intact skin of rabbits was treated with 1.0 ml of test item, which was used diluted in 50 % DMSO. The irritation was measured by patch test technique on the intact skin. After 4 hours, the patches were removed and the resulting reactions were evaluated on the basis of the code of Federal Regulations, Title 16, Section 1500.41.

None of the animals showed any observable response to treatment throughout the 72 hours observation period.

The irritation score was 0.0 and the substance has been judged to be non irritating, according to the ETAD-Subcommittee for Toxicology.

Conclusion

The scoring system criteria used to record the hardness of the skin reactions followed in the current test are the same as those reported into the OECD guideline, therefore it is possible to re-evaluate the results in accordance with the CLP Regulation (EC) No 1272/2008.

None of the animals showed any observable response to treatment throughout the 72 hours observation period, thus it can be concluded that the test item does not meet the criteria to be classified as irritating, according to the CLP Regulation (EC) No 1272/2008.